Shots:
Regulatory momentum accelerated globally with multiple biosimilars securing key approvals and positive opinions, including Sandoz’s Enzeevu (Eylea biosimilar) in the US and Canada, Accord BioPharma’s Filkri (Neupogen biosimilar) US FDA approval, EC approvals for Gotenfia (Simponi biosimilar) and Ranluspec (Lucentis biosimilar), and CHMP positive opinions for tocilizumab and insulin biosimilars.
Strategic partnerships expanded regional access as companies including Alvotech, Bio-Thera Solutions, Formycon,…
Shots:
Alvotech reported positive top-line data from the AVT80-GL-P01 PK study comparing AVT80 with Entyvio in healthy adults
The study met all 1EP, demonstrating PK similarity between AVT80 & Entyvio following a single 108mg/0.68mL SC dose, supporting AVT80’s biosimilar profile
Alvotech is developing AVT16 (IV) & AVT80 (SC) as Entyvio’s biosimilars, with the AVT80-GL-P01 study…

